Pharma Validation Engineer – GMP Specialist

MSD Malaysia; Carlow; Hybrid; EUR 85,000 - 110,000; Full time

Job summary

MSD is seeking an Engineering Specialist (Validation) for its Carlow site in Ireland. The role supports Cleaning Validation & Recovery teams in a cGMP setting, delivering qualification/validation activities and change controls.

You will liaise with Production, Maintenance and Quality, drive continuous improvement, and participate in audits and regulatory submissions as needed. The successful candidate will have strong validation experience, knowledge of DeltaV/Pi System, and a proven track

Qualifications

• Relevant technical qualification in pharmaceutical/biological/chemical sciences or engineering.
• Proven track record delivering validation/execution in cGMP environments.
• Experience with Tank CIP and Parts Washers in-process components.
• Experience with cleaning recovery studies and TOC/swab methods.

Responsibilities

• Design/author/review/approve/execute qualification/validation docs and cycle development.
• Design/author/review/approve/execute change controls.
• Resolve technical issues during study execution.
• Collaborate with Production, Maintenance and Quality during Cycle Development & PQ.
• Provide technical input for investigations and quality notifications.
• Perform root cause analysis on system failures and performance issues.
• Support Lean Six Sigma continuous improvement initiatives.
• Represent validation in cross-functional projects and global forums.
• Ensure compliance with GMP and regulatory requirements in daily activities.
• Maintain documentation, risk assessments, and corrective actions; support audits.
• Assist regulatory audits and submissions as required.
• Promote a safe, compliant culture on site; perform other duties as assigned.

Skills

Validation expertise

CGMP knowledge

Project management

Data analysis

Communication skills

Education

Applied Pharmaceutical/ Biological/ Chemical sciences degree

Tools

DeltaV

Pi System

MS Office

Job description

MSD is seeking an Engineering Specialist (Validation) for its Carlow site in Ireland. The role supports Cleaning Validation & Recovery teams in a cGMP setting, delivering qualification/validation activities and change controls.

You will liaise with Production, Maintenance and Quality, drive continuous improvement, and participate in audits and regulatory submissions as needed. The successful candidate will have strong validation experience, knowledge of DeltaV/Pi System, and a proven track